An open label study examining the long term safety of exenatide given twice daily to patients with type 2 diabetes mellitus.

Eli Lilly and Company Ltd0 个研究点目标入组 500 人开始时间: 2006年12月22日最近更新: 2012年12月17日

适应症

试验速览

暂无简介。

•[1]Patients received exenatide therapy in Study H8O-MC-GWAA or Study H8O-MC-GWAD and completed the study (Visit 9 of Study H8O-MC-GWAA or Visit 11 of Study H8O-MC-GWAD).
•[2]Patients must have given informed consent for Study H8O-MC-GWAN in accordance with local regulations.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Patients were excluded or discontinued early from Study H8O-MC-GWAA or Study H8O-MC-GWAD.
•2. Female patients of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause):
•·intend to become pregnant during the study,
•·refuse to use a reliable method of birth control during the study, as determined by the investigator.
•3. Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that renders them unable to understand the nature, scope, and possible consequences of the study or precludes them from following and completing the protocol, in the opinion of the investigator.
•4. Patients fail to satisfy the investigator of suitability to participate for any other reason.
•5. Patients have received treatment within the last 30 days with a drug, not including exenatide, that has not received regulatory approval for any indication at the time of study entry.
•6. Patients are investigative site personnel directly affiliated with the study, or are immediate family of investigative site personnel directly affiliated with the study.
•7. Patients are employed by Lilly or Amylin. Immediate family of Lilly or Amylin employees may participate in Lilly-sponsored or Lilly-managed clinical trials, but are not permitted to participate at a Lilly facility.

发起方

Eli Lilly and Company Ltd